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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-MC-KGBI | Other Identifier | Eli Lilly and Company | |
| DRM06-AD13 | Other Identifier | Dermira Inc | |
| 2021-005232-29 | EudraCT Number | ||
| 2022-501476-25-00 | Other Identifier | EU Trial Number |
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| Name | Class |
|---|---|
| Dermira, Inc. | INDUSTRY |
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The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab (Cohort 1) | Experimental | Participants who are 6 years to <18 years of age, 12 years to <18 years of age who weigh <40 kilogram (kg) or 6 years to <12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight. |
|
| Lebrikizumab (Cohort 2) | Experimental | Participants who are 6 months to <6 years of age, 2 years to <6 years of age or 6 months to <2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matching lebrikizumab by SC injections with a TCS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline | EASI-75 is a co-primary endpoint with IGA. | Baseline to Week 16 |
| Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score | IGA is a co-primary endpoint with EASI-75. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score | Baseline to Week 16 | |
| Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline |
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Inclusion Criteria:
Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least,
Have an EASI score ≥16 at the screening and baseline
Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline
Have ≥10% BSA of AD involvement at the screening and baseline.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Phoenix Children's Hospital |
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| Label | URL |
|---|---|
| A Study of Lebrikizumab (LY3650150) in Participants 6 Months to \<18 Years of Age With Moderate-to-Severe Atopic Dermatitis | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Placebo | Drug | Placebo given SC |
|
| Topical Corticosteroid (TCS) | Drug | TCS administered |
|
| Baseline to Week 16 |
| Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16 | Baseline to Week 16 |
| Percentage Change from Baseline in EASI Score | Baseline, Week 16 |
| Percentage Change from Baseline in Pruritus NRS Score | Baseline, Week 16 |
| Change from Baseline in Children Dermatology Life Quality Index (cDLQI) | Baseline, Week 16 |
| Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS) | Baseline, Week 16 |
| Change from Baseline in Body Surface Area (BSA) | Baseline, Week 16 |
| Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD) | Baseline, Week 16 |
| Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score | Baseline to Week 16 |
| Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration | Week 14 |
| Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) | Week 14 |
| Percentage of Participants with a Worst Scratching/Itching NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline to Week 16 | Baseline to Week 16 |
| Change from Baseline in SCORAD | Baseline, Week 16 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Arkansas Research Trials | North Little Rock | Arkansas | 72217 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Antelope Valley Clinical Trials | Lancaster | California | 93534 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
| Rady's Children Hospital San Diego - Dermatology | San Diego | California | 92123 | United States |
| UConn Health | Farmington | Connecticut | 06030-2840 | United States |
| Solutions Through Advanced Research | Jacksonville | Florida | 32256 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Allergy & Asthma Specialists, P.S.C. | Owensboro | Kentucky | 42301 | United States |
| Respiratory Medicine Research Institute of Michigan, PLC | Ypsilanti | Michigan | 48197 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| Dermatologists of Central States, LLC | Fairborn | Ohio | 45324 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| CONEXA Investigacion Clinica S.A. | Buenos Aires | 1012 | Argentina |
| Instituto de Neumonología Y Dermatología | Buenos Aires | 1425 | Argentina |
| Derma Internacional | Buenos Aires | 1426 | Argentina |
| Psoriahue | Buenos Aires | C1425DKG | Argentina |
| Fundación Respirar | Buenos Aires | C1426ABP | Argentina |
| Fundacion Estudios Clinicos | Rosario | S2000DEJ | Argentina |
| Cornerstone Dermatology | Coorparoo | 4151 | Australia |
| Sydney Children's Hospital | Randwick | 2031 | Australia |
| The Children's Hospital at Westmead | Westmead | 2145 | Australia |
| Veracity Clinical Research | Woolloongabba | 4102 | Australia |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | 14784400 | Brazil |
| Centro de Pesquisa Sao Lucas | Campinas | 13060-803 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | 90035-903 | Brazil |
| Hospital de Clínicas de Ribeirão Preto | Ribeirão Preto | 14051-140 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | 20241-180 | Brazil |
| Faculdade de Medicina do ABC | Santo André | 09060-870 | Brazil |
| Clinica de Alergia Martti Antila | Sorocaba | 18040-425 | Brazil |
| Dermatology Research Institute | Calgary | T2J 7E1 | Canada |
| DermEdge Research | Mississauga | L4Y 4C5 | Canada |
| Fakultni nemocnice Bulovka | Prague | 180 81 | Czechia |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Rosenpark Research GmbH | Darmstadt | 64283 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | 60590 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Asahikawa Medical University Hospital | Asahikawa | 078-8510 | Japan |
| Fukuyama City Hospital | Fukuyama | 721-8511 | Japan |
| Osaka Habikino Medical Center | Habikino | 583-8588 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Ina Central Hospital | Ina | 396-0033 | Japan |
| Enomoto Clinic | Kumagaya | 360-0018 | Japan |
| University Hospital,Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Okayama City General Medical Center Okayama City Hospital | Okayama | 700-8557 | Japan |
| National Hospital Organization Sagamihara National Hospital | Sagamihara | 252-0392 | Japan |
| Dermatology and Ophthalmology Kume Clinic | Sakai | 593-8324 | Japan |
| Sugamo Sengoku Dermatology | Toshima City | 170-0002 | Japan |
| Fujita Health University | Toyoake | 470-1192 | Japan |
| Scientia Investigacion Clinica S.C. | Chihuahua City | 31207 | Mexico |
| PanAmerican Clinical Research - Cuernavaca | Cuernavaca | 62290 | Mexico |
| Hospital de Jesús Nazareno | Mexico City | 06090 | Mexico |
| Trials in Medicine | Mexico City | 06700 | Mexico |
| Hospital Infantil de Mexico Federico Gomez | Mexico City | 06720 | Mexico |
| Eukarya PharmaSite | Monterrey | 64718 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | 66460 | Mexico |
| Arké SMO S.A de C.V | Veracruz | 91900 | Mexico |
| Instituto Dermatologico de Jalisco | Zapopan | 45190 | Mexico |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | 80-546 | Poland |
| Diamond Clinic | Krakow | 31-559 | Poland |
| "DERMED" Centrum Medyczne Sp. z o.o. | Lodz | 90-265 | Poland |
| Centrum Medyczne Evimed | Warsaw | 02-625 | Poland |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | 08950 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín | Las | 35010 | Spain |
| Grupo Pedro Jaén | Madrid | 28006 | Spain |
| Hospital Infantil Universitario Niño Jesús | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Clinica Universidad de Navarra | Pamplona | 31008 | Spain |
| National Taiwan University Hospital - Hsinchu branch | Hsinchu | 300 | Taiwan |
| Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist | 83301 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Chang Gung Memorial Hospital-Taipei | Taipei | 105 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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